Polyaxial Bone Anchor With Spline Capture Connection And Lower Pressure Insert

ABSTRACT

A medical implant assembly includes a polyaxial bone anchor having a shank with an upper portion, a receiver, a retainer for holding the shank upper portion in the receiver, a lower compression insert with surfaces for closely receiving an elongate connecting member and a closure structure that may independently engage the lower compression insert to lock the shank with respect to the receiver while selectively not locking the elongate member. Projections or splines of the shank upper portion mate with holding pockets on the retainer. The bone anchor includes a shank upper surface exclusively engaging the lower compression insert that is spaced from the retainer, the retainer and shank being configured for polyaxial motion with respect to the receiver prior to locking.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. Ser. No. 12/661,986, filed Mar. 26, 2010 which claimed the benefit of U.S. Provisional Patent Application Ser. No. 61/211,169, filed Mar. 27, 2009 and incorporated by reference herein.

U.S. Ser. No. 12/661,986 was also a continuation-in-part of U.S. patent application Ser. No. 12/587,244 filed Oct. 2, 2009 that is a continuation of U.S. patent application Ser. No. 10/818,554, filed Apr. 5, 2004, now U.S. Pat. No. 7,662,175, that is both a continuation-in-part of U.S. patent application Ser. No. 10/651,003 filed Aug. 28, 2003 and a continuation of U.S. patent application Ser. No. 10/464,633 filed Jun. 18, 2003, now U.S. Pat. No. 6,716,214, all of which are incorporated herein by reference herein.

U.S. Ser. No. 12/661,986 was also a continuation-in-part of U.S. patent application Ser. No. 12/154,460 filed May 23, 2008 that claims the benefit of U.S. Provisional Application No. 60/931,362 filed May 23, 2007, and is a continuation-in-part of U.S. patent application Ser. No. 11/140,343 filed May 27, 2005, all of which are incorporated by reference herein. The Ser. No. 12/154,460 application is also a continuation-in-part of U.S. patent application Ser. No. 10/818,555 filed Apr. 5, 2004 that is a continuation of U.S. patent application Ser. No. 10/464,633 filed Jun. 18, 2003, now U.S. Pat. No. 6,716,214 and a continuation-in-part of U.S. patent application Ser. No. 10/651,003, filed Aug. 28, 2003, all of which are incorporated by reference herein.

U.S. Ser. No. 12/661,986 was also a continuation-in-part of U.S. patent application Ser. No. 12/290,244 filed Oct. 29, 2008 that claims the benefit of U.S. Provisional application Ser. No. 61/000,964 filed Oct. 30, 2007 and that is a continuation-in-part of U.S. patent application Ser. No. 11/522,503 filed Sep. 14, 2006 that is a continuation-in-part of U.S. patent application Ser. No. 11/024,543 filed Dec. 20, 2004, now U.S. Pat. No. 7,204,838, all of which are incorporated by reference herein.

BACKGROUND OF THE INVENTION

The present invention is directed to polyaxial bone anchors for use in spinal surgery and especially to such anchors that are in the form of a polyaxial bone screw adapted to receive a longitudinal connecting member and secure such a member to a vertebra.

Many spinal surgery procedures require securing various implants to bone and especially to vertebrae along the spine. For example, longitudinal connecting members such as elongate rods are often required that extend along the spine to provide support to vertebrae that have been damaged or weakened due to injury, disease or the like. Such rods must be supported by certain vertebra and support other vertebra. The most common mechanism for providing such structure is to implant bone screws into certain bones which then in turn support the rod or are supported by the rod. Bone screws of this type may have a fixed head or rod receiver relative to a shank thereof. In the fixed bone screws, the receiver cannot be moved relative to the shank and the rod or other longitudinal connecting member must be favorably positioned in order for it to be placed within the receiver. This is sometimes very difficult or impossible to do so polyaxial bone screws are commonly used. Polyaxial bone screws allow rotation of the head or receiver about the shank until a desired rotational position is achieved for the receiver relative to the shank after which the longitudinal connecting member can be inserted and the position of the receiver eventually locked with respect to movement relative to the shank.

The present invention is directed to such swivel head type bone screws and, in particular, to swivel head bone screws having an open head or receiver that allows placement of the longitudinal connecting member within the receiver and then subsequent closure by use of a closure top, plug or the like to capture the connector in the receiver of the screw.

SUMMARY OF THE INVENTION

A polyaxial bone anchor according to the invention includes a shank, a receiver, a lower compression or pressure insert and a retainer that operably cooperate with one another, the shank and the retainer being coupled and not pivotal or swivelable with respect to each other, but both equally swivelable with respect to the receiver until locked into place. The shank includes at least one lateral projection or spline that engages the retainer which is positioned below a top surface of the shank. In some embodiments, locking of the position of the shank with respect to the receiver is obtained by direct engagement between a bottom surface of a closure top and an upper surface of the lower pressure insert. The bone anchor is designed to allow the shank to be locked or secured in a selected angular configuration with respect to the receiver via the lower pressure insert, while locking or slidably capturing an elastic or inelastic longitudinal connecting member. The longitudinal connecting member may include, but is not limited to a hard rod or a softer deformable rod, a hard or deformable bar and even a cord. The longitudinal connecting member can be made of metallic or non-metallic material. The lower pressure insert exclusively contacts the shank at an upper surface thereof. The pressure insert remains spaced from the retainer in any and all selected angular configurations of the shank with respect to the receiver. With the polyaxial mechanism locked, the longitudinal connecting member, for example a rod or a cord, can either be locked in place or not locked and free to slide through the receiver. Freedom to slide through the locked receiver occurs if the rod or cord has a reduced diameter with respect to the pressure insert.

Objects of the invention include providing spinal implants and assemblies that have a low profile are easy to use and extremely effective for the intended usage thereof.

Other objects and advantages of this invention will become apparent from the following description taken in conjunction with the accompanying drawings wherein are set forth, by way of illustration and example, certain embodiments of this invention.

The drawings constitute a part of this specification and include exemplary embodiments of the present invention and illustrate various objects and features thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an enlarged and exploded perspective view of a polyaxial bone screw assembly according to the invention including a bone screw shank, a receiver, a retaining structure, a lower pressure insert and a closure structure.

FIG. 2 is an enlarged top plan view of the shank of FIG. 1.

FIG. 3 is an enlarged front elevational view of the retainer of FIG. 1.

FIG. 4 is an enlarged top plan view of the retainer of FIG. 1.

FIG. 5 is an enlarged perspective view of the retainer of FIG. 1.

FIG. 6 is an enlarged top plan view of the lower pressure insert of FIG. 1.

FIG. 7 is an enlarged bottom plan view of the lower pressure insert of FIG. 1.

FIG. 8 is an enlarged cross-sectional view taken along the line 8-8 of FIG. 6.

FIG. 9A is an enlarged and partial front elevational view of the bone screw assembly of FIG. 1 shown in a stage of assembly, with crimped projections of the receiver holding the insert in frictional engagement with the shank, the shank and retainer being in non-floppy frictional, but movable engagement with the receiver, with portions broken away to show the detail thereof.

FIG. 9B is an enlarged and partial front elevational view of the bone screw assembly of FIG. 1 shown in an assembled, locked position (but without a longitudinal connecting member), with portions broken away to show the detail thereof.

FIG. 10 is an enlarged and partial side elevational view, showing three bone screws of FIG. 1 and a longitudinal connecting member in the form of a rod.

FIG. 11 is an enlarged and partial side elevational view of one of the bone screws of FIG. 10 and the rod, with portions broken away to show the detail thereof.

FIG. 12 is an enlarged and partial cross-sectional view taken along the line 12-12 of FIG. 11.

FIG. 13 is an enlarged and exploded perspective view of an alternative embodiment of a polyaxial bone screw assembly according to the invention including a bone screw shank, a receiver, a retaining structure, a cylindrical lower pressure insert and shown with a bar and a closure structure.

FIG. 14 is an enlarged and partial front elevational view of the shank, receiver, retaining structure and pressure insert of FIG. 13 with portions broken away to show the detail thereof.

FIG. 15 is an enlarged and partial perspective view of the shank, receiver, retaining structure, pressure insert and bar of FIG. 13 with portions broken away to show the detail thereof.

DETAILED DESCRIPTION OF THE INVENTION

As required, detailed embodiments of the present invention are disclosed herein; however, it is to be understood that the disclosed embodiments are merely exemplary of the invention, which may be embodied in various forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present invention in virtually any appropriately detailed structure. It is also noted that any reference to the words top, bottom, up and down, and the like, in this application refers to the alignment shown in the various drawings, as well as the normal connotations applied to such devices, and is not intended to restrict positioning of the connecting member assemblies of the application and cooperating bone anchors in actual use.

With reference to FIGS. 1-12, the reference number 1 generally represents a polyaxial bone screw apparatus or assembly in accordance with the present invention operably utilized by implantation into a vertebra (not shown) and in conjunction with a longitudinal connecting member, such as an illustrated rod 3 so as to operably secure the rod 3 in a fixed position relative with respect to the vertebra (not shown).

The fully assembled bone anchor assembly 1 includes a shank 6, a receiver 7, a retainer structure or ring 8, a lower pressure insert 9 and a closure structure or top 10. With particular reference to FIGS. 1, 2 and 9-12, the shank 6 is elongate and has an upper body portion 14 integral with a lower body portion 15, ending in a tip 16. The shank body 15 has a helically wound bone implantable thread 17 extending from near the tip 16 to near the top 18 of the lower body 15 and extending radially outward therefrom. During use, the body 15 utilizing the thread 17 is implanted into a vertebra. The shank 6 has an elongated axis of rotation generally identified by the reference letter A.

Axially extending outward and upward from the shank body 15 is a neck 20, typically of reduced radius as compared to the adjacent top 18 of the body 15. Further extending axially and outwardly from the neck 20 is the shank upper portion 14 operably providing a connective or capture structure free from the bone or vertebra for joining with the receiver 7. With particular reference to FIG. 2, the shank upper portion or capture structure 14 has a radially outer cylindrical surface 22. The cylindrical surface 22 has at least one non-helically wound and radially outward or lateral extending projection or spline 24 that extends beyond the surface 22. In the embodiment shown in FIGS. 1-12, the shank upper portion 14 has three such laterally extending splines 24. It is noted that bone anchors of the invention have at least one and up to a plurality of splines 24. Preferably, the bone anchor includes from one to four splines. The splines 24 are located near and extend outwardly from an upper edge 25 of the shank upper portion cylindrical surface 22 and are equally circumferentially centered and spaced thereabout so as to be centered at approximately 120 degree intervals relative to each other. Each of the splines 24 has a substantially triangular shaped profile and a front wedge forming face 27 that slopes downwardly and radially inwardly from near the upper edge 25. Adjacent the upper edge 25 is a centrally located, axially extending and upwardly directed convex annular projection or dome-shaped upper end 29 that is centrally radiused. Each of the splines 24 includes an upper surface 30 that is adjacent to and extends from the upper end surface 29, having the same radius as the upper end surface 29. Also formed in the shank upper portion 14 within an annular rim 28 of the end surface 29 is a tool engagement aperture 31 for engagement by a tool driving head (not shown) that is sized and shaped to fit into the aperture for both driving and rotating the shank 6 into a vertebra. In the illustrated embodiment, the aperture 31 is star-shaped and runs parallel to the axis A. It is foreseen that various sizes, shapes and numbers of apertures, slots or the like may be utilized in accordance with the invention for engaging a driving tool of suitable and similar mating shape. The illustrated shank 6 is cannulated, having a through bore 32 extending an entire length of the shank 6 along the axis A. The bore 32 is defined by an inner cylindrical wall of the shank 6 and has a circular opening at the shank tip 6 and an upper opening communicating with the internal drive feature 31. The bore 32 provides a passage through the shank 6 interior for a length of wire (not shown) inserted into the vertebra (not shown) prior to the insertion of the shank body 15, the wire providing a guide for insertion of the shank body 15 into the vertebra (not shown).

To provide a biologically active interface with the bone, the threaded shank body 15 may be coated, perforated, made porous or otherwise treated. The treatment may include, but is not limited to a plasma spray coating or other type of coating of a metal or, for example, a calcium phosphate; or a roughening, perforation or indentation in the shank surface, such as by sputtering, sand blasting or acid etching, that allows for bony ingrowth or ongrowth. Certain metal coatings act as a scaffold for bone ingrowth. Bio-ceramic calcium phosphate coatings include, but are not limited to: alpha-tri-calcium phosphate and beta-tri-calcium phosphate (Ca₃(PO₄)₂, tetra-calcium phosphate (Ca₄P₂O₉), amorphous calcium phosphate and hydroxyapatite (Ca₁₀(PO₄)₆(OH)₂). Coating with hydroxyapatite, for example, is desirable as hydroxyapatite is chemically similar to bone with respect to mineral content and has been identified as being bioactive and thus not only supportive of bone ingrowth, but actively taking part in bone bonding.

With reference to FIG. 1, the receiver 7 has a generally squared-off U-shaped appearance with a partially cylindrical inner profile and a substantially faceted outer profile; however, the outer profile could also be of another configuration, for example, curved or cylindrical. A receiver axis of rotation B is aligned with the axis of rotation A of the shank 6 during assembly of the receiver 7 with the shank 6 and the retainer 8. After the receiver 7 is pivotally connected to the shank 6, and such assembly is implanted in a vertebra (not shown), the axis B is typically disposed at an angle with respect to the axis A of the shank 6.

With particular reference to FIGS. 1 and 9-12, the receiver 7 has a base 33 with a pair of upstanding arms 34 and 35 forming a U-shaped channel 38 between the arms 34 and 35 with a lower seat 39 having a slightly larger radius than the rod 3 for operably receiving the rod 3. The insert 9 that is disposed within the receiver 7 snugly receives the rod 3 as will be described more fully below. Each of the arms 34 and 35 has an interior surface 41 that includes a partial helically wound guide and advancement structure 42. In the illustrated embodiment, the guide and advancement structure 42 is a partial helically wound flangeform that mates under rotation with a similar structure on the closure top 10, as described below. However, it is foreseen that the guide and advancement structure 42 could alternatively be a buttress thread, a reverse angle thread or other thread like or non-thread like helically wound advancement structures for operably guiding under rotation and advancing the closure top between the arms 34 and 35. Tool engaging apertures 44 are formed on the outsides of the arms 34 and 35 for holding the receiver 7 during certain assembly steps and/or implantation of the assembly and also for access to a thin deformable wall 45 during assembly with the pressure insert 9.

A chamber or cavity 47 is located within the receiver base 33 that opens upwardly into the U-shaped channel 38. The cavity 47 includes a partial spherical shaped surface 48, at least a portion of which forms a partial internal hemispherical seat for the retainer 8, as is described further below. The hemispherical shaped surface 48 has a second radius associated therewith. A lower neck 50 defining a lower bore further communicates between the cavity 47 and the bottom exterior of the base 33 and is coaxial with the rotational axis B of the receiver 7. The neck 50 at least partially defines a restriction having a radius which is smaller than the radius of the retainer 8, so as to form a restrictive constriction at the location of the neck 50 relative to the retainer 8 to prevent the retainer 8 from passing between the cavity 47 and the lower exterior of the receiver 7. In an upper portion of the cavity 47, adjacent to the spherical surface 48, is a substantially cylindrical surface 52 that includes a run-out surface 53 located directly beneath the guide and advancement structure 42.

With particular reference to FIGS. 3-5, the retainer 8 is substantially ring-shaped and has an operational central axis which is the same as the elongate axis A associated with the shank 6, but when the retainer 8 is separated from the shank 6, the axis of rotation is identified as axis C. The retainer 8 has a central bore 57 that passes entirely through the retainer 8 from a top surface 58 to a bottom surface 59 thereof. The bore 57 is sized and shaped to fit snugly but slidably over the shank capture structure cylindrical surface 22 in such a manner as to allow sliding axial movement therebetween under certain conditions, as described below. Three axially aligned channels 60 are spaced from the axis C and extend radially outward from the bore 57 and into the wall of the retainer 8 so as to form three top to bottom grooves or slots therein. Backs 61 of the channels 60 are the same radial distance from the axis C as the distance the outermost portion of the splines 24 extend from the axis A of the shank 6. The channels 60 are also circumferentially angularly spaced equivalent to and have a width that corresponds with the splines 24. In this manner, the shank upper portion 14 can be uploaded into the retainer 8 by axially sliding the shank upper portion 14 through the retainer 8 central bore 57 whenever the splines 24 are aligned with the channels 60 or are in an aligned configuration. The details of assembly and subsequent cooperation between the shank 6, the retainer 8 and the receiver 7 are described in detail in Applicant's U.S. Pat. No. 6,716,214 issued Apr. 6, 2004, the entire disclosure of which is incorporated by reference herein.

The retainer 8 also has three capture partial slots, holding pockets, receivers or recesses 62 which extend radially outward from the upper part of the bore 57 and that do not extend the entire length from top to bottom of the retainer 8, but rather only open on the top surface 58 and extend partly along the height of the retainer 8 thereof. The holding pockets or recesses 62 are sized and positioned and shaped to receive the splines 24 from above when the splines 24 are in a non-aligned configuration relative to the channels 60. That is, each of the recesses or pockets 62 has a width that approximates the width of the splines 24 and has a mating wedge engaging surface 64 that is shaped similar to the spline wedge forming faces 27, so that the splines 24 can be slidably received into the recesses 62 from above by axially translating or moving the shank 6 downward relative to the retainer ring 8 when the splines 24 are positioned above the recesses 62 in a recess aligned configuration. In some embodiments, the wedge engaging faces 64 slope slightly greater than the wedge forming faces 27 on the splines 24 so that there is additional outward wedging that takes place when the splines 24 are urged downwardly into the recesses 62.

In this manner the shank upper portion 14 can be uploaded or pushed upwardly through the retainer central bore 57 so as to clear the top 58 of the retainer ring 8, rotated approximately 60 degrees and then downloaded or brought downwardly so that the splines 24 become located and captured in the recesses 62. Once the splines 24 are seated in the recesses 62 the shank 6 cannot move further axially downward relative to the retainer ring 8. Preferably, the retainer 8 is constructed of a metal or other material having sufficient resilience and elasticity as to allow the retainer 8 to radially expand slightly outward by downward pressure of the splines 24 on the recesses 62 under pressure from structure above, as will be discussed further below. This produces a slight outward radial expansion in the retainer ring 8 at the location of the recesses 62.

The retainer 8 has a radially outer partial hemispherical shaped surface 65 sized and shaped to mate with the partial spherical shaped surface 48 and having a third radius approximately equal to the second radius associated with the surface 48. The retainer 8 third radius is substantially larger than the radius associated with the annular curved surface 29 of the shank upper portion 14 and also substantially larger than the radius of the receiver neck 50.

With particular reference to FIGS. 6-8, the lower compression or pressure insert 9 includes a substantially cylindrical body 70 integral with a pair of upstanding arms 72. The body 70 and arms 72 form a generally U-shaped, open, through-channel 74 having a lower seat 76 sized and shaped to closely, snugly engage the rod 3. As shown in the alternative embodiment of FIGS. 13-15, the insert 9 may be configured to include planar holding surfaces that closely hold a square or rectangular bar as well as hold a cylindrical rod-shaped or corded longitudinal connecting member. The arms 72 disposed on either side of the channel 74 extend outwardly from the body 70. The arms 72 are sized and configured for placement near the run-out 53 below the guide and advancement structure 42 at the receiver inner arms 34 and 35. As will be discussed in greater detail below, each of the arms 72 includes a top surface 78 ultimately located directly beneath the guide and advancement structure 42 and are directly engaged by the closure top 10 for locking the polyaxial mechanism of the assembly 1, even without a longitudinal connecting member as shown in FIG. 9B. Therefore, the assembly 1 may be used with a wide variety of longitudinal connecting members, including rods that engage the closure top 10 and are locked into position by such closure top 10 as well as rods of smaller diameter or cords that are captured by the closure top 10, but are otherwise movable within the receiver 7 and are thus in slidable or spaced relation with the closure top 10. In this manner, the locked polyaxial open screw can function like a closed, fixed monoaxial screw. Each arm 72 further includes a partially cylindrical outer surface 80 sized and shaped to fit within the receiver 7 at the guide and advancement structure 42 run-out relief 53. The cylindrical surfaces 80 are disposed substantially perpendicular to the respective adjacent top surfaces 78. In some embodiments of the invention recesses are formed near and/or at the top surfaces 78 and the surfaces that form the channel 74 to provide relief for material flow of the longitudinal connecting member, when, for example, the connector is made from a deformable plastic or elastic or inelastic polymer. For example, a recessed surface or groove may be directed downwardly and inwardly toward the channel 74. Each of the outer surfaces 80 further includes a recess 82 sized and shaped to receive holding tabs or crimped material from the receiver 7. As illustrated in FIG. 12, for example, the thin walls 45 of the receiver 7 are pressed into the recesses 82 to prevent rotation of the insert 9 about the axis B with respect to the receiver 7. In other embodiments of the invention, the receiver 7 may be equipped with spring tabs that snap into the recesses 82 to hold the insert 9 in place with respect to rotation. The recesses 82 are oval or elongate such that some desirable upward and downward movement of the insert 9 along the axis B of the receiver 7 is not prohibited.

The compression insert 9 further includes an inner cylindrical surface 84 that forms a through bore sized and shaped to receive a driving tool (not shown) therethrough that engages the shank drive feature 31 when the shank body 15 is driven into bone. The inner surface 84 runs between the seating surface 76 and an inner curved, annular, radiused or semi-spherical surface 86. The surface 86 is sized and shaped to slidingly and pivotally mate with and ultimately fix against the annular domed surface 29 of the shank upper portion 14. Thus, a radius of the surface 86 is the same or substantially similar to the radius of the surface 29. The surface 86 may include a roughening or surface finish to aid in frictional contact between the surface 86 and the surface 29, once a desired angle of articulation of the shank 6 with respect to the receiver 7 is reached. Adjacent to the inner surface 86 is a bottom rim or edge 88. Adjacent to the outer cylindrical surface 80 of the arms 72 is a substantially conical surface 90 that extends inwardly toward the lower rim 88. The surface 90 includes portions of the arms 72 as well as partially defining the pressure insert body 70. In some embodiments of the invention, the surface 90 terminates at the rim 88. In the illustrated embodiment, the insert 9 is further trimmed near the base rim 88 to ensure clearance between the insert 9 and the retainer 8. Specifically a v-shaped cut is formed in the insert 9 near the rim 88, the cut being defined by sloping surfaces 92 and 93. The surface 92 is adjacent the base rim 88 and the surface 93 is located between the surface 92 and the surface 90.

The pressure insert body 70 located between the arms 72 has an outer diameter slightly smaller than a diameter between crests of the guide and advancement structure 42 of the receiver 7 allowing for top loading of the compression insert 9 into the receiver 7 through the U-shaped channel 38, with the arms 72 being located between the arms 34 and 35 during insertion of the insert 9 into the receiver 7. Once located between the guide and advancement structure 42 and the shank upper portion 14, the insert 9 is rotated into place about the axis B until the arms 72 are directly below the guide and advancement structure 42 at or near the run-out 53. After the insert 9 is rotated into such position, a tool (not shown) may be inserted into the receiver apertures 44 to press the thin receiver walls 45 into the insert recesses 82. The lower compression insert 9 is sized such that the insert 9 is ultimately received within the cylindrical surface 52 of the receiver 7 below the guide and advancement structure 42. The receiver 7 fully receives the lower compression insert 9 and blocks the structure 9 from spreading or splaying in any direction. It is noted that assembly of the shank 6 with the retainer 8 within the receiver 7, followed by insertion of the lower compression insert 9 into the receiver 7 are assembly steps typically performed at the factory, advantageously providing a surgeon with a polyaxial bone screw with the lower insert 9 already held in alignment with the receiver 7 and thus ready for insertion into a vertebra.

The compression or pressure insert 9 ultimately seats on the shank upper portion 14 and is disposed substantially in the upper cylindrical portion 52 of the cavity 47, with the receiver deformable walls 45 engaging the insert 9 at the recesses 82, thereby holding the insert 7 in desired alignment with respect to the longitudinal connecting member 3. The assembly may be configured so that the insert 9 extends at least partially into the U-shaped channel 38 such that the seating surface 76 substantially contacts and engages an adjacent surface of the rod 3 when the rod 3 is placed in the receiver 7 and the closure structure or top 10 is tightened against the rod, the illustrated rod 3 being fixedly held in spaced relation with the lower seat 39 of the receiver 7. As will be further noted below, in some embodiments, a cord or smaller diameter rod may be held in sliding engagement with the insert 9, the shank 6 being locked into a desired position by engagement of the closure top 10 with the insert 9 and engagement of the insert 9 with the shank upper portion 14, which in turn presses the retainer 8 against the receiver seating surface 48.

With particular reference to FIGS. 10-12, the elongate connecting member illustrated in the drawing figures is a hard, inelastic solid cylindrical rod 3 of circular cross-section the diameter of which can vary depending on the application. However, longitudinal connecting members for use with the assembly 1 may take a variety of shapes, including but not limited to rods or bars of oval, rectangular or other curved or polygonal cross-section. In the alternative, the size and shape of the insert 9 channel may be modified so as to loosely hold or more closely hold, and if desired, fix the longitudinal connecting member to the assembly 1. The assembly 1 may also be used with an elastic tensioned cord. Such a cord may be made from a variety of materials, including polyester or other plastic fibers, strands or threads, such as polyethylene-terephthalate. In any event, the polyaxial screw can be securely locked when using any of the longitudinal connecting members. Furthermore, the longitudinal connector 3 may be a component of a longer overall dynamic stabilization connecting member, with cylindrical or bar-shaped portions sized and shaped for being received by the compression insert 9 of the receiver 7 having a u-shaped channel (or rectangular- or other-shaped channel) for loosely or more closely receiving the longitudinal connecting member. The longitudinal connecting member 3 may be integral or otherwise fixed to a bendable or damping component that is sized and shaped to be located between adjacent pairs of bone screw assemblies 1, for example. A damping component or bumper may surround and/or be attached to the member 3 at one or both sides of the bone screw assembly 1 and the bumper may engage the screw head. A rod or bar (or rod or bar component) of a longitudinal connecting member may be made of a variety of materials ranging from deformable plastics to hard metals, depending upon the desired application. Thus, bars and rods of the invention may be made of materials including, but not limited to metal and metal alloys including but not limited to stainless steel, titanium, titanium alloys and cobalt chrome; or other suitable materials, including plastic polymers such as polyetheretherketone (PEEK), ultra-high-molecular weight-polyethylene (UHMWP), polyurethanes and composites, including composites containing carbon fiber, natural or synthetic elastomers such as polyisoprene (natural rubber), and synthetic polymers, copolymers, and thermoplastic elastomers, for example, polyurethane elastomers such as polycarbonate-urethane elastomers.

With reference to FIGS. 1 and 10-12, the closure structure or closure top 10 can be any of a variety of different types of closure structures for use in conjunction with the present invention with suitable mating structure on the upstanding arms 34 and 35. In the embodiment shown, the closure top 10 is rotatably received between the spaced arms 34 and 35 of the receiver 7. The illustrated closure structure 10 is substantially cylindrical and includes an outer helically wound guide and advancement structure 95 in the form of a flange form that operably joins with the guide and advancement structure 42 of the receiver 7. The flange form utilized in accordance with the present invention may take a variety of forms, including those described in Applicant's U.S. Pat. No. 6,726,689, which is incorporated herein by reference. It is also foreseen that according to the invention the closure structure guide and advancement structure could alternatively be a buttress thread, a square thread, a reverse angle thread or other thread like or non-thread like helically wound advancement structure for operably guiding under rotation and advancing the closure structure 10 downward between the arms 34 and 35 and having such a nature as to resist splaying of the arms 34 and 35 when the closure structure 10 is advanced into the channel 38. The illustrated closure structure 10 also includes a top surface 96 with an internal drive 97 in the form of an aperture that is illustrated as a star-shaped internal drive, but may be, for example, a hex-shaped drive or other internal drives, including, but not limited to slotted, tri-wing, spanner, two or more apertures of various shapes, and the like. A driving tool (not shown) sized and shaped for engagement with the internal drive 97 is used for both rotatable engagement and, if needed, disengagement of the closure 10 from the receiver arms 34 and 35. It is also foreseen that the closure structure 10 may alternatively include a break-off head designed to allow such a head to break from a base of the closure at a preselected torque, for example, 70 to 140 inch pounds. Such a closure structure would also include a base having an internal drive to be used for closure removal. A bottom surface 98 of the closure top 10 is planar, but could be domed or radiused and may include a point, points, a rim or roughening for engagement with the rod 3. Furthermore, in some embodiments, the closure top may include an extended base, central cylinder, cap or knob for pressing into a deformable rod or compressing a cord or cable against the insert seating surface. Such an extension or knob would be sized and shaped to extend into the channel 74 of the insert and also clear the walls defining the channel 74 so that a portion of the closure top still abuts against the insert 9, locking the polyaxial mechanism of the bone screw.

The illustrated bottom surface 98 of the closure top 10 is sized and shaped for engagement with the top planar surfaces 78 of the arms 72 of the lower pressure or compression insert 9. As illustrated in FIG. 9B, engagement of the surface 98 with the surfaces 78 independently locks the polyaxial mechanism of the bone screw 1, the insert 9 being pushed downwardly toward the shank upper portion 14 by the closure 10 that in turn presses the retainer 8 against the receiver 7 at the seating surface 48. In some embodiments of the invention, and as illustrated in FIGS. 11 and 12, the surface 98 of the closure top 10 also can barely touch or firmly frictionally engage the rod 3, capturing and/or locking the rod in position between the closure top 10 and the insert 9. In other embodiments of the invention, a smaller rod, cable or cord may remain in sliding engagement with the closure top 10 with the top 10 being only in frictional engagement with the insert 9 to lock the polyaxial mechanism of the assembly 1 and fix the angular configuration of the shank 6 with respect to the receiver 7 without fixing the rod, cable or cord captured by the receiver 7 and between the insert and the closure top 10. Also, depending upon the material of the rod 3, with time, the rod 3 may undergo creep or other plastic deformation that may lessen the engagement between the cylindrical surface of the rod 3 and the closure surface 98. However, regardless of any movement and/or change in position or angulation of the rod with respect to the receiver, the frictional engagement between the closure member 10 and the lower compression insert 9, both preferably made from a metal or metal alloy, such as cobalt chrome, stainless steel or titanium, will remain rigid and secure.

The closure top 10 may further include a cannulation through bore extending along a central axis thereof and through a surface of the drive 97 and the bottom surface 98. Such a through bore provides a passage through the closure 10 interior for a length of wire (not shown) inserted therein to provide a guide for insertion of the closure top into the receiver arms 34 and 35, after which the wire could be removed and the rod, cable or cord could then be threaded or inserted through the receiver.

When the polyaxial bone screw assembly 1 is placed in use in accordance with the invention the retainer 8 is normally first slid through the receiver U-shaped channel 38 and into and seated in the receiver cavity 47. Thereafter, the retainer 8 is rotated 90 degrees so as to be coaxial with the receiver 7 and so that the retainer outer surface 65 snugly but slidably mates with the receiver interior spherical shaped surface 48. The retainer 8 in the receiver 7 is then slid over the shank upper portion 14 so that the splines 24 slide upwardly through and above respective channels 60 so that the splines 24 are then located, at least partially, in the U-shaped channel 38 and chamber 47 above the retainer ring 8. The shank 6 is then rotated 60 degrees relative to the receiver about the axis A and the translational direction of the shank 6 is reversed so that it goes downwardly or axially with respect to the receiver 7, and the splines 24 enter the recesses 62. At this point there is no substantial outward or downward pressure on the retainer 8 and so the retainer 8 is easily rotatable along with the shank 6 within the chamber 47 and such rotation is of a ball and socket type wherein the angle of rotation is only restricted by engagement of the neck 20 with the neck 50 of the receiver 7.

Then, the insert 9 is inserted into the channel 38 with the arms 72 aligned in the channel 38 between the guide and advancement structures 42. The insert 9 is then moved downwardly in the channel 38 and toward the cavity 47. Once the arms 72 are located generally below the guide and advancement structure 42 and adjacent the run-out relief 53, the insert 9 is rotated about the axis B of the receiver 7. The arms 72 fit within the cylindrical walls 52 above the cavity 47. Once the arms 72 are located directly below the guide and advancement structures 42, rotation is ceased and a tool (not shown) is used to press the thin walls 45 of the receiver 7 into the recesses 82 of the insert 9. The insert 9 is now locked into place inside the receiver 7 with the guide and advancement structures 42 prohibiting upward movement of the insert 9 out of the channel 38 and the crimped walls 45 preventing rotation of the insert 9. As illustrated in FIGS. 9A, 9B, 11 and 12, the insert 9 seats on the shank upper portion 14 with the surface 86 in sliding engagement with the surface 29. The run-out or relief 53 is sized and shaped to allow for some upward and downward movement of the insert 9 toward and away from the shank upper portion 14 such that the shank 6 is pivotable with respect to the receiver 7 until the closure structure 10 presses on the insert 9 that in turn presses upon the upper portion 14 into locking frictional engagement with the receiver 7 at the surface 48. This assembly process is generally performed by the manufacturer. With particular reference to FIG. 9A, the walls 45 may be crimped at a location with respect to the insert aperture 44 that causes the surface 86 of the insert 9 to bias against and frictionally engage the shank domed surface 29 to provide a sub-assembly in which the shank 6 is pivotable with respect to the receiver 7, but in a non-floppy manner, making it easier for a surgeon to position the receiver 7 at a desired articulation with respect to the shank 6 and have the assembly hold such desired position prior to insertion of the rod 3 or other longitudinal connecting member.

The sub-assembly as shown in FIG. 9A is then normally screwed into a bone, such as vertebra, by rotation of the shank 6 using a suitable driving tool (not shown) that operably drives and rotates the shank 6 by engagement thereof at the internal drive 31. Normally, the receiver 7, retainer 8 and insert 9 are assembled on the shank 6 before placing the shank 6 in the vertebra, but in certain circumstances, the shank 6 can be first implanted with the capture structure 14 extending proud to allow assembly and then the shank 6 can be further driven into the vertebra.

A rod 3 is eventually positioned within the receiver U-shaped channel 38, as is seen in FIGS. 10-12, and the closure top 10 is then inserted into and advanced between the arms 34 and 35 so as to bias or push against the insert 9 (and here, the rod 3 also). A driving tool (not shown) is inserted into the drive 97 to rotate and drive the closure top 10 into the receiver 7. The shank dome 29 is engaged by the insert 9 and pushed downwardly when the closure top 10 pushes downwardly on the insert 9, as is seen in FIG. 12. The downward pressure on the shank 6 in turn urges the splines 24 downwardly which exerts both a downward and outward thrust on the retainer ring 8. Three polyaxial bone screws 1, including the rod 3, are shown in FIG. 10, illustrating various shank 6 to receiver 7 angular configurations. Furthermore, FIGS. 11 and 12 illustrate a particular angular configuration in which the axis A of the bone screw shank 6 is not coaxial with the axis B of the receiver 7 and the shank 6 is locked in this angular locked configuration.

If removal of the assembly 1 is necessary, the assembly 1 can be disassembled by using a driving tool mating with the closure top aperture 97 to rotate the closure top 10 and reverse the advancement thereof in the receiver 7. Then, disassembly of the remainder of the assembly 1 may be accomplished in reverse mode in comparison to the procedure described above for assembly.

Illustrated in FIGS. 13-15 is a second embodiment of a bone screw assembly, generally 201, according to the present invention. The assembly includes a shank 206, a receiver 207, a retainer 208, a cylindrical lower pressure insert 209 and a closure top 210 having a break-off head. The assembly is shown with a longitudinal connecting member in the form of a bar 203. The shank 206 includes an upper portion 214 that is substantially similar in form and function to the portion 14 of the shank 6 of the assembly 1 and the retainer ring 208 is substantially similar in form and function to the retainer ring 8 of the assembly 1. The receiver 207 is somewhat similar to the receiver 7 of the assembly 1 and differences between the receiver 7 and the receiver 207 include the feature of spring tabs 221 for holding the insert 209 within the receiver 207 and planar seating surfaces 239, 240 and 241 for receiving the bar 203.

The pressure insert 209 includes a substantially cylindrical body with an outer cylindrical surface 280. The insert also includes a lower spherical surface 286 sized and shaped for slidably mating with an upper domed surface 229 of the shank upper portion 214. The insert 209 includes a planar top surface 278 upon which the bar 203 is received. In use, the closure top 210 presses upon the bar 203 that in turn presses upon the insert 209 that presses directly upon the shank upper portion 229 and not upon the retainer 208. Downward movement of the shank upper portion 229 that is fixed to the retainer 208 then in turn presses an outer spherical surface 265 of the retainer 208 against an inner seating surface 248 of the receiver 207. As shown in FIG. 15, when the shank 206 is disposed at an angle with respect to the receiver 207, the insert 209 remains spaced from the retainer 208 and does not make contact with the retainer 208 in any angular configuration of the shank 206 with respect to the receiver 207.

It is to be understood that while certain forms of the present invention have been illustrated and described herein, it is not to be limited to the specific forms or arrangement of parts described and shown. 

What is claimed and desired to be secured by Letters Patent is as follows:
 1. A polyaxial bone anchor comprising: a) a shank having a body for fixation to a bone and an integral upper portion, the upper portion having a top radiused surface and at least one laterally directed projection; b) a receiver having a top portion and a base, the receiver top portion defining an open channel, the base having a seating surface partially defining a cavity, the channel communicating with the cavity, the cavity communicating with an external of the base through an opening sized and shaped to receive the shank upper portion therethrough; c) a compression insert disposed in the receiver, the insert having a lower mating surface; and d) a retainer having an external surface with a radius larger than the shank top radiused surface and a central bore with an internal surface defining the central bore having at least one substantially vertical channel for slideably receiving the projection therethrough and at least one pocket for downwardly receiving and holding the projection of the shank upper portion, the shank upper portion and the retainer being in fixed relation to one another, both the upper portion and the retainer being in swivelable relation within the receiver, providing selective angular positioning of the shank with respect to the receiver, the retainer external surface being in slidable engagement with the receiver seating surface during positioning, the compression insert lower mating surface engaging and applying a downward locking pressure to the shank without engaging the retainer such that the retainer is spaced from the compression insert at any and all angular positions of the shank with respect to the receiver.
 2. The bone anchor of claim 1 further comprising a closure top engaging the compression insert to lock the angular position of the shank with respect to the receiver.
 3. The bone anchor of claim 1 wherein the receiver has a projected wall surface engaging the compression insert.
 4. The bone anchor of claim 3 wherein the projected wall surface prevents rotational movement of the compression insert.
 5. The bone anchor of claim 3 wherein the projected wall surface biases the compression insert into non-locking frictional engagement with the shank upper portion.
 6. The bone anchor of claim 1 wherein the shank is cannulated.
 7. The bone anchor of claim 1 wherein the shank has an internal drive feature.
 8. A polyaxial bone screw assembly comprising: a) a receiver having a channel adapted to receive an elongate longitudinal member and having a lower restrictive neck; b) a compression insert located in the receiver and adapted to engage the elongate longitudinal member; c) a shank having a lower portion adapted to be implanted in a bone of a patient and an upper portion having at least one laterally directed projection and a top radiused surface; the shank upper portion being sized and shaped to be positioned in the receiver so as to have the shank extend through the lower restrictive neck; d) a retainer ring separate from the shank, received in the receiver and adjacent the lower restrictive neck; the retainer ring mating with and non-pivotably coupled to the shank upper portion by downward positioning of the laterally directed projection into a holding pocket in the retainer ring, the upper portion and retainer ring being polyaxially rotatable together through various angular configurations relative to the receiver prior to locking of the position of the shank relative to the receiver, the retainer ring width being larger than a width of the receiver lower restrictive neck so as to hold the shank upper portion in the receiver while allowing polyaxial movement of the shank relative to the receiver during positioning and having an upper radiused surface that is substantially greater in radius than the shank top radiused surface; and e) the shank upper portion being sized, shaped and positioned to engage the compression insert and receive a downward force from the compression insert; the retainer being sized and shaped so as to be free from engagement with the compression insert in all angular configurations of the shank and retainer relative to the receiver.
 9. The bone screw assembly of claim 8 wherein the retainer ring is spaced from and located below a top surface of the shank upper portion, the retainer ring being unengaged with the compression insert at any and all angular positions of the shank with respect to the receiver.
 10. A polyaxial bone anchor comprising: a) a shank having a body adapted for anchoring to a bone and an upper portion having a top surface; the top surface being radiused and having a first radius; b) a receiver having an inner cavity that operably receives the shank upper portion through an aperture in the bottom of the cavity; the cavity having a seating surface; and c) a retainer separate from the shank that includes structure to operably join with the shank in the receiver cavity and polyaxially rotate with the shank relative to the receiver during positioning; the retainer having a lower surface sized and shaped to be rotatably received on the receiver cavity seating surface; the retainer having a second radius wherein the second radius is larger than the shank top surface first radius; the shank upper portion top surface extending above the retainer.
 11. The bone anchor according to claim 10 including a compression insert operably positioned in the receiver so as to engage the shank upper portion top surface and being free of engagement with the retainer such that application of a downward force to the compression insert during use is thereafter applied to the shank.
 12. The bone screw anchor according to claim 11 including: a) a connecting rod received in the receiver above the compression insert and operably engaging the compression insert in use; b) wherein the receiver includes a channel openably receiving the rod; and including c) a closure for openably closing the channel above the rod and applying a downward force to the rod to be transferred through the insert to the shank so as to thereafter secure the position of the shank and retainer in a locked configuration relative to the receiver. 